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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020886
Company: ADVANZ PHARMA

Products on NDA 020886

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PANRETIN	ALITRETINOIN	EQ 0.1% BASE	GEL;TOPICAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020886

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/02/1999	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20886lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20886ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20886.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/17/2025	SUPPL-9	Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Patient Package Insert	Label (PDF) Letter (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020886s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/020886Orig1s009ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/020886Orig1s009ltr.pdf
11/22/2013	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
11/21/2000	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
07/12/1999	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for NDA 020886

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/17/2025	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020886s009lbl.pdf
11/17/2025	SUPPL-9	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020886s009lbl.pdf
11/17/2025	SUPPL-9	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020886s009lbl.pdf
02/02/1999	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20886lbl.pdf

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